兽用中药玉屏风口服液质量标准提升研究

Study on improvement of quality standard of Yupingfeng oral liquid

关键词:  高效液相色谱  玉屏风口服液  升麻素苷  5-O-甲基维斯阿米醇苷  毛蕊异黄酮葡萄糖苷  

Key words:  HPLC  Yupingfeng oral liquid  Glucoside  5-O-methylvisamitol glycoside  Calycosin isoflavones glucoside.

摘要:

目的：建立一种可同时测定玉屏风口服液中升麻素苷、5-O-甲基维斯阿米醇苷、毛蕊异黄酮葡萄糖苷含量的高效液相色谱法（HPLC）。方法：采用以十八烷基硅烷键合硅胶为填充剂的色谱柱(5μm 4.6×250mm)，以乙腈和0.2%磷酸溶液为流动相进行梯度洗脱，流速1.0mL·min-1，柱温30℃，检测波长254nm，进样体积10μL。结果：检测的三种成分在测定的质量浓度范围内线性关系良好，r值均为0.999，平均加样回收率均在96%～102%之间，相对标准偏差均小于2.0%。试验精密度、重复性、准确性和稳定性良好。结论：新建立的检测方法简单、准确、高效，为进一步提升玉屏风口服液的质量控制提供了依据。

Abstract:

[Abstract]Objective:To establish a high performance liquid chromatography (HPLC) method for the simultaneous determination of glucoside, 5-O-methyl Visamitol side and calynoisoflavone glucoside in Yupingfeng oral liquid. Methods: The chromatography was performed on a column (5μm 4.6×250mm) with acetonitrile and 0.2% phosphoric acid as the fillers. The flow rate was 1.0mL·min-1. The column temperature was 30℃. The detection wavelength was 254nm and the sample volume was 10μg. Results: The linear relationship of the three components was good in the range of mass concentration, r values were 0.999, the average recoveries were between 96% and 102%, and the relative standard deviations were less than 2.0%. The test has good precision, repeatability, accuracy and stability. Conclusion: The newly established detection method is simple, accurate and efficient, which can provide a basis for the quality control of Yupingfeng oral liquid.